Prescription drug · NDA
Metadate Cd (methylphenidate hydrochloride) NDC 69654-584
Methylphenidate hydrochloride 60 mg/1 · Capsule, Extended release · Oral · Aytu BioPharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69654-584-30 | 69654058430 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-584-30)Marketed from Feb 22, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Metadate Cd
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 60 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Aytu BioPharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021259
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 69654-584_43e0b75f-01c3-28cd-e063-6394a90a74a8SPL ID 43e0b75f-01c3-28cd-e063-6394a90a74a8SPL set ID be59f8b4-7842-42cc-9559-bfa747f0baa5RxCUI 1091139, 1091163, 1091178, 1091193, 1091204, 1091220, 1806181, 1806187, 1806189, 1806191, 1806193, 1806197UNII 4B3SC438HIUPC 0369654583308, 0369654579301, 0369654581304, 0369654584305, 0369654582301, 0369654580307
- Pharmacologic class
- Central Nervous System Stimulant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469654058430followed by a unit qualifier and the quantityPackage 69654-0584-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
METADATE CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of METADATE CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ). Use in Specific Populations ( 8.4 )] . METADATE CD is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age ( 1 ) Limitations of Use The use of METAD…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021259
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-580 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-579 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-581 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-582 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-583 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4579 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4580 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4581 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6579 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6580 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4582 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4583 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6581 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6582 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4584 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6583 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6584 |